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Childhood Sexual Abuse, Vaginismus and Labor Dystocia (CSA-V-LD)

Primary Purpose

Child Abuse, Vaginismus, Dystocia

Status
Unknown status
Phase
Locations
Israel
Study Type
Observational
Intervention
Sponsored by
Hillel Yaffe Medical Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Child Abuse focused on measuring Childhood sexual abuse, Vaginismus, Partial vaginismus, Labor dystocia, Depression

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • pregnant women in their third trimester

Exclusion Criteria:

  • alcohol addiction
  • drug addiction
  • mental retardation
  • active psychopathology

Sites / Locations

  • Department of Obstetrics and Gynecology, Hillel-Yaffe Medical Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
January 25, 2012
Last Updated
February 8, 2012
Sponsor
Hillel Yaffe Medical Center
Collaborators
The Baruch Padeh Medical Center, Poriya
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1. Study Identification

Unique Protocol Identification Number
NCT01530113
Brief Title
Childhood Sexual Abuse, Vaginismus and Labor Dystocia
Acronym
CSA-V-LD
Official Title
Childhood Sexual Abuse, Vaginismus and Labor Dystocia: Towards a Theoretical Model
Study Type
Observational

2. Study Status

Record Verification Date
January 2012
Overall Recruitment Status
Unknown status
Study Start Date
March 2012 (undefined)
Primary Completion Date
March 2014 (Anticipated)
Study Completion Date
March 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hillel Yaffe Medical Center
Collaborators
The Baruch Padeh Medical Center, Poriya

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The study aims to develop a theoretical model explicating the inter-relationships between Childhood Sexual Abuse (CSA), Partial Vaginismus (PV) and Labor Dystocia (LD), including their associations with Depression (D) as a mediating variable. The following research hypotheses will be tested: CSA will serve as a risk factor for D, PV and LD. pregnant women with a history of CSA will have higher levels of D compared to pregnant women without a history of CSA. pregnant women with a history of CSA will have more PV compared to pregnant women without a history of CSA. pregnant women with a history of CSA will have higher levels of LD compared to pregnant women without a history of CSA. D will serve as a mediator between prenatal PV and LD. PV will serve as a risk factor for LD. postpartum PV will be affected by childbirth (LD vs. no LD) contingent on the level of D.
Detailed Description
Previous studies indicate that childhood sexual abuse has long term implications to women's psychological and physical well-being; among them, depression, a plethora of gynecological symptoms and labor dystocia. Literature in the field also suggests that childhood sexual abuse may be a contributing factor to total and/or partial vaginismus: psycho-sexual disorders associated with significant difficulty and pain during attempted penetration, pelvic examinations and/or sexual relations. The proposed quantitative longitudinal study aims to develop a theoretical model explicating the relationships between: childhood sexual abuse, prenatal and postpartum partial vaginismus, and childbirth (labor dystocia versus no labor dystocia); including their associations with depression as a mediating variable. Questionnaire responses of pregnant women (Hebrew/Arabic speakers) from the Hillel-Yaffe medical center in Israel will be included in the study. Data collection will be extended across three time periods: prenatal (third trimester of pregnancy), within one month postpartum, and approximately six months postpartum. Study questionnaires will probe participant's socio-demographic and gynecological history, traumatic life events, sexual experiences, level of depression, partial vaginismus and sexual distress and the objective and subjective severity of their childbirth experience. Simulations for this project were carried out to help set statistical significance goals and to determine the sample size needed to achieve these goals. From these simulations, a sample size of N=2000 was determined to be adequate and cost effective, to determine standard deviations SD (defining confidence interval ±SD) of about 0.022 for the correlations. The potential significance of the study is twofold: Theoretically, the study represents a first of its kind effort to explore the relationships between child sexual abuse, prenatal and postpartum partial vaginismus, childbirth and depression, in a single comprehensive longitudinal research study. Practically, the study may potentially assist a wide range of health care professionals by: providing a developing theory for evidence-based practice. showing the need for integration of women's past history into prenatal and postnatal care as a means of lowering the risk for a traumatic birth experience and later psychological distress. aiding in the development of intervention models for the treatment of women with a history of child sexual abuse and/or vaginismus during pregnancy and childbirth.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Child Abuse, Vaginismus, Dystocia, Depression
Keywords
Childhood sexual abuse, Vaginismus, Partial vaginismus, Labor dystocia, Depression

7. Study Design

Enrollment
2000 (Anticipated)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: pregnant women in their third trimester Exclusion Criteria: alcohol addiction drug addiction mental retardation active psychopathology
Study Population Description
Pregnant women in their third trimester
Sampling Method
Non-Probability Sample
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mordechai Hallak, M.D, Prof.
Phone
972-4-6304244
Email
mottih@hy.health.gov.il
First Name & Middle Initial & Last Name or Official Title & Degree
Hila Sharabi, M.D
Phone
972-52-823-5268
Email
drhilash@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mordechai Hallak, M.D, Prof.
Organizational Affiliation
Hillel Yaffe Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rachel Lev-Wiesel, Ph.D, Prof.
Organizational Affiliation
Haifa University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hila Sharabi, M.D
Organizational Affiliation
Hillel Yaffe Medical Center
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Ruth Gottfried, Ph.D Student
Organizational Affiliation
Haifa University
Official's Role
Study Director
Facility Information:
Facility Name
Department of Obstetrics and Gynecology, Hillel-Yaffe Medical Center
City
Hadera
ZIP/Postal Code
38100
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mordechai Hallak, M.D, Prof.

12. IPD Sharing Statement

Learn more about this trial

Childhood Sexual Abuse, Vaginismus and Labor Dystocia

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